Good Clinical Practice: A Question and Answer Guide2024/2025 Edition - 41

Investigators/Sites - Statement of Investigator Included (Global)
2.22 Q. Assume that a female who is enrolled in a clinical trial becomes pregnant while on the trial and is then
withdrawn from the study. If the sponsor wants to continue to collect information on the patient's medical
outcome/history, is a new and separate consent required? What are the investigator responsibilities?
A. In a recent informal response to this question, the FDA's Good Clinical Practice Program noted that, " [we]
will assume the subject(s) have already received the investigational drug, or there would be no concern, just a
notation in the study records that the subject withdrew prior to treatment as a result of pregnancy. The fact that
you are speaking about withdrawal from the study also implies... that pregnancy is an exclusion condition in the
study protocol. If the subject has received the investigational drug, it would be necessary to follow that individual
for safety reasons and, in general, no further consent should be required if only protocol-specific information is
collected.
Unless further treatment with the investigational product were part of the protocol, there would be no reason for
the subject to be withdrawn from the study. Instead, she should have the required follow-up visits-for both her
safety and to ensure full data collection on the use of the investigational drug. Her data would need to be analyzed
separately from other participants-but that is the sponsor's concern. Even if further doses of the investigational
drug were part of the protocol, the subject should still not be completely withdrawn from the study, since followup
is essential for safety reasons-once again for both the subject's sake and to ensure all pertinent information
resulting from administration of the investigational drug is properly captured. As above, her data would need to be
analyzed separately.
Additional informed consent would be required to obtain any additional information about pregnant study
subjects, whether retrospectively or through new diagnostic procedures. Such data collection was not part of the
original study for which the subject gave her informed consent and FDA considers collection of this follow-up
information as human subject research. With few exceptions, FDA-regulated research with human subjects requires
informed consent from the participants. In addition, the reviewing institutional review board (IRB) would consider
collection of additional information from a study subject an amendment to the original protocol they had reviewed
and approved. They would, therefore, need to review and approve the protocol for such data collection and the
accompanying informed consent document. The investigator would be required to submit the required paperwork
to the IRB to include a new consent form and would be required to re-consent the patient if/once approved.
2.23 Q. In what ways, if any, is the clinical investigator's (or other parties involved in the research process)
access to the patient's medical record or other confidential information limited if the patient withdraws
from the study?
A. It is important to distinguish between several types of data and information regarding the patient. First, the
study-related records and data compiled before the subject's withdrawal from the study remain part of the clinical
study data, and there should be no limitation on access to this information throughout the course of the study (even
the portions from which the subject has withdrawn). The degree of the clinical investigator's access to the subject's
medical record or other confidential information will depend on the subject's consent following his/her withdrawal.
" An investigator may ask a subject who is withdrawing whether the subject wishes to provide continued followup
and further data collection after their withdrawal from the interventional portion of the study, " says the FDA in
its October 2008 guidance titled, " Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials. "
" Under this circumstance, the discussion with the subject would distinguish between study-related interventions
and continued follow-up of associated clinical outcome information, such as medical course or laboratory results
obtained through non-invasive chart review and address the maintenance of privacy and confidentiality of the
subject's information. If a subject withdraws from the interventional portion of the study but agrees to continued
follow-up of associated clinical outcome information as described [above], the investigator must obtain the
subject's informed consent for this limited participation in the study (assuming such a situation was not described
in the original informed consent form). In accordance with FDA regulations, IRB approval of informed consent
documents would be required. " In a November 2008 guidance titled, " Guidance on Important Considerations
for When Participation of Human Subjects in Research is Discontinued, " HHS calls such situations " a partial
discontinuation of a subject's participation in research. " [Note: In September 2010, HHS also issued a guidance
titled, " Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues, " which the
HHS said includes " interpretations [that] do not conflict with those provided in FDA's guidance document. " ]
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Good Clinical Practice: A Question and Answer Guide2024/2025 Edition

Table of Contents for the Digital Edition of Good Clinical Practice: A Question and Answer Guide2024/2025 Edition